Regulatory Compliance Specialist

4 tygodni temu

Warszawa, Mazovia, Polska Roche Pełny etat

The Role

Regulatory Compliance Specialist

At Roche, we are committed to delivering quality and compliance in an efficient manner. As a Regulatory Compliance Specialist, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle.

You will be responsible for assuring that Roche's regulated/critical systems and services adhere to regulatory standards (CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business.

Key Responsibilities

  • Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).
  • Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.
  • Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements.
  • Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems.
  • Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution.
  • Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas.

Stakeholder Management and Partnering

  • Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product.
  • Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes.
  • Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices.

Impact and Complexity

  • Define and manage product service levels, governance and operational support model aligned with stakeholder needs.
  • Lead or coordinate quality and compliance discussions.
  • Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations.
  • Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements.
  • Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.
  • Ensure information risk assessment process and implementation guidelines are followed.

Requirements

  • Exhibits servant and creative leadership (VACC) behavior.
  • Exhibits a Lean-Agile Mindset and excels at Product Management practices.
  • Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity.
  • Has a keen Quality & Regulatory focus: You are passionate about major trends.
  • Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity.
  • Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.
  • Exhibits ability to empower teams and individuals to act autonomously and hold them accountable.
  • Exhibits intellectual curiosity and integrity and has a strong passion for innovation.
  • Understanding of health regulatory frameworks (FDA, GxP).
  • Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR).
  • Experience with control automation.

What We Offer

  • Salary range 21 000 - 26 000 PLN grossbased on the employment contract (Umowa o pracę).
  • Annual bonus payment based on your performance.
  • Dedicated training budget (training, certifications, conferences, diversified career paths etc.).
  • Highly flexible working arrangements - you have an impact on your daily schedule and you will work with your manager on how often you visit our office.
  • Recharge Fridays (2 Fridays off per quarter available).
  • Take time Program (up to 3 months of leave to use for any purpose).
  • Flex Location (possibility to perform our work from different places in the world for a certain period of time).
  • Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).
  • Private healthcare (Medicover packages) and group life insurance (UNUM).
  • Stock share purchase additions.
  • Yearly sales of company laptops and cars and many more.

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